FDA.reportPublic FDA data

I.S.E. K

Primary DI
05055273210538
Brand
I.S.E. K
Company
RANDOX LABORATORIES LIMITED
Model
D200-0015
Catalog number
D200-0015
Device description
Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEMElectrode, Ion Specific, Potassium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024014000RANDOX RX DAYTONARandox Laboratories, Ltd.2003-12-04CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273210538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273210538050552732105385055273210538

GMDN Terms#

Term, Definition table
TermDefinition
Potassium (K+) electrode IVDAn electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of potassium (K+) ions in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+44289445170technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03
05055273200034ALBAB3800AB38002016-09-16
05055273200041ALBAB362AB3622016-09-16
05055273200058ALBAB3800AB38002016-09-16
05055273208115ALBAB8301AB83012016-09-16
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273203400GLUTATHIONE REDUCTASE (GLUT RED)GR23682019-06-03
05055273203417GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL)GR26082019-06-03
05055273203424GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL)GR26092019-06-03
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380740156855ARCHITECTABBOTT LABORATORIESCEM2019-10-31
00380740163372ARCHITECTAbbott GmbHCEM2019-08-15
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00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONCEM2019-02-14
00386100001650ISE Disposable Reference Electrode MEDICA CORPORATIONCEM2018-12-11
00386100002503Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002541EasyElectrolyte Reagent Module, Na/K/Cl AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002794ISE Cleaning Solution KitMEDICA CORPORATIONCEM2018-12-11
00386100002817ISE Reagent PackMEDICA CORPORATIONCEM2018-12-11
00386100002831ISE Reagent ModuleMEDICA CORPORATIONCEM2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002596pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100002633Bi-Level QC Kit, HCTMEDICA CORPORATIONCEM2018-12-05
00386100002664Reagent ModuleMEDICA CORPORATIONCEM2018-12-05
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100002879Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002886Lithium Na/K/Li AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002893Calcium Na/K/Ca/pH AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003043Na/K/Cl Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003067Na/K/Ca/pH Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100003074Na/K/Li Solution PackMEDICA CORPORATIONCEM2018-12-04